Status:
TERMINATED
Combination of Serum Measurements of Molecular Biomarkers and Serum Protein Profiling Can be Used to Predict Which Patients Undergoing Prostatic Biopsy Will be Diagnosed With Cancer
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
National Institutes of Health (NIH)
New York Presbyterian Hospital
Conditions:
Prostate Cancer
Elevated Prostate Specific Antigen (PSA)
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
This is a prospective, serum proteomics study of men who are to undergo prostate biopsy. The purpose is to determine if proteomic profiles can be used to distinguish between men with prostate cancer o...
Eligibility Criteria
Inclusion
- Men aged 18 years or older
- Have a PSA level between 2 and 10 ng/ml
- May or may not have an abnormal digital rectal examination
- Scheduled for trans-rectal ultrasound (TRUS) guided systematic prostate biopsy as part of routine medical care. All sites (Department of Urology at SUNY Downstate Medical Center, Brooklyn, the Department of Urology, New York Presbyterian Hospital, Weill Medical College of Cornell University, Manhattan and the Department of Urology, Kings County Hospital) will perform a standardized 14 core biopsy protocol.
- Signed, informed consent
- Patient must be able to attend the pre-biopsy blood draw
Exclusion
- Any period of prior/current treatment with hormonal therapy (LHRH agonist/antagonist,antiandrogen, 5-alpha-reductase inhibitor)
- Prior pelvic radiation
- A period of less than 6 months prior/current treatment with an alpha-blocker
- Previous diagnosis of prostate cancer
Key Trial Info
Start Date :
October 14 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 8 2024
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT00773773
Start Date
October 14 2008
End Date
March 8 2024
Last Update
September 4 2024
Active Locations (4)
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1
Kings County Hopsital Center
Brooklyn, New York, United States
2
SUNY Downstate Medical Center (DMC)
Brooklyn, New York, United States
3
Memorial Sloan Kettering Cancer Center (All protocol activites)
New York, New York, United States, 10065
4
Weill Medical College of Cornell University
New York, New York, United States